Month: February 2024

Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations

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Informed Consent to Psychedelic-Assisted Psychotherapy: Ethical Considerations
Research Article
Andrew Lee, Daniel Rosenbaum, Daniel Z. Buchman
The Canadian Journal of Psychiatry, 17 January 2024
Excerpt
…Given that psychedelics can induce powerful nonordinary states of consciousness and increase suggestibility, challenges surrounding the informed consent process in [Psychedelic-Assisted Psychotherapy] PAP have begun to receive attention. For example, Smith and Sisti suggest that a process of “enhanced consent” be undertaken prior to PAP, characterized by special attention to the shifts in personality and values that can follow a psychedelic experience, the possible mental health side effects of psychedelics, and the possible use of therapeutic touch during treatment. However, Jacobs argues that owing to the particular effects of psychedelics—namely, mystical and ego-dissolution experiences which can occur acutely after administration and longer-term shifts in identity and values—the typical standards for informed consent may not be feasible.

Issues of capacity and consent during the psychedelic experience have received less attention. Individuals using psychedelics often experience profound acute changes to their sensorium along with alterations in mood, detachment from the body, and distortions of their sense of self, time, and reality. Consequently, it may be difficult for patients to appreciate the risks and benefits of terminating the session during the psychedelic experience. It may also be difficult for observers to predict or interpret the internal process and distress of patients during sessions, as their observable behaviour may not be representative of their inner experience…

Informed consent for capacity assessment

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Informed consent for capacity assessment
Shaun T. O’Keeffe, Mary Donnelly
International Journal of Law and Psychiatry, January–February 2024
Abstract
In this paper we examine the role of informed consent to capacity assessment, focussing primarily on the two jurisdictions of England and Wales, and Ireland. We argue that in both jurisdictions, a capacity assessment should be regarded as a distinct intervention, separate from the ‘original’ intervention at issue, and that specific informed consent to the assessment should generally be sought in advance. As part of this, we consider what information should be provided so as to ensure informed consent. Having established a baseline requirement for informed consent, we also recognise that informed consent to assessment will not always be possible, either because the person is unable to understand the information about assessment or because the person refuses to be assessed and so, in the final part of the article, we explore how to proceed when informed consent is either not possible or not forthcoming, including an analysis of the implications of the statutory presumption of capacity.

Capacity to consent to treatment in severe eating disorders

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Capacity to consent to treatment in severe eating disorders
Research Article
Giovanna Parmigiani, Lorenzo Tarsitani, Fabiano Grassi, Gabriele Mandarelli, Stefano Ferracuti
International Review of Psychiatry, 12 January 2024
Abstract
Eating disorders represent a disabling, deadly and costly condition, whose principal treatment is constituted by weigh restoration and psychotherapy. Partial or total refuse of treatment is very common, leading some authors to question their decision-making capacity (DMC) to consent to treatment. However, very few studies have investigated treatment DMC, leading to contrasting results. Forty-five women were enrolled at the Psychiatric and Eating Disorders Unit of the University Hospital Policlinico Umberto I of Rome. Psychiatric symptoms severity (Brief Psychiatric Rating Scale Expanded, BPRS-E), treatment DMC (MacArthur Competence Assessment Tool for Treatment, MacCAT-T), depressive symptoms (Hamilton Depression Rating Scale, HAM-D), anxiety symptoms (Hamilton Anxiety Rating Scale, HAM-A), symptoms and psychological characteristics of eating disorders (Eating Disorder Inventory, EDI-3) and Metacognitive beliefs (Metacognitions Questionnaire 30, MCQ-30) were assessed. Sixty-seven percent of the total sample showed low treatment DMC; specifically, 70.4% of patients affected by Anorexia Nervosa, 72.7% of patients affected by Bulimia Nervosa, and 42.9% of patients affected by Binge Eating Disorder. Specific psychopathological symptoms enhance or hamper patients’ decisional capacities. Clinicians should be aware of the risk of impaired DMC in this vulnerable group of patients and pay attention at those factors suggesting the need of an in-depth evaluation.

Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study

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Comparing Anxiety Levels and Pain Scores for Video-assisted and Traditional Informed Consent in Extracorporeal Shockwave Lithotripsy: A Prospective, Randomised, Controlled Study
Nurul Zubaidah Shahul Hameed, Devindran Manoharan, Lee Say Bob, Susan Woo
Asian Journal of Research and Reports in Urology, 23 January 2024
Abstract
Aims
Traditionally, informed consent involves verbal and/or written material provided to the patient by a treating clinician. Multimedia interventions improve patients’ knowledge and understanding during the informed consent process. This study aimed to compare pre-procedural anxiety levels and pain scores between educational video-assisted informed consent and traditional informed consent for extracorporeal shockwave lithotripsy (ESWL) at our centre.
Study Design
This was a prospective, randomised, controlled study conducted at two centres.
Place and Duration of Study
The study was conducted in two Urology centre Department of Urology, Penang General Hospital and Department of Urology, Hospital Kuala Lumpur between 15th May 2022 and 15th October 2022.
Methodology
The study group consisted of all adult patients undergoing ESWL in both centres. A video presentation explaining the ESWL procedure was developed in two languages, and group allocation was randomised using a computer-based random number generator. Anxiety levels were assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) questionnaire, visual analogue scale, and numerical rating scale used to collect data on pain scores.
Results
A total of 54 respondents, with a predominance of male patients (57.4%) and the majority of patients having completed secondary school education (53.7%). In comparing the two groups, the video-assisted respondents exhibited significantly lower anxiety scores regarding the procedure than those in the traditional group (p< 0.05). However, there were no statistically significant differences between the groups in terms of pain scores, both pre- and post-procedural.
Conclusion
Video-assisted informed consent can reduce procedure-related patient anxiety levels before ESWL; however, there was no difference in pain scores between the two consent methods. patients.

Practicing care-full scholarship: Exploring the use of ‘visual informed consent’ in a study of motherhood, health and agroecology in Coventry, UK

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Practicing care-full scholarship: Exploring the use of ‘visual informed consent’ in a study of motherhood, health and agroecology in Coventry, UK
Research Article
Mai Abbas, Alex Franklin, Stefanie Lemke, Chiara Tornaghi
Qualitative Research, 10 January 2024
Open Access
Abstract
The demand for alternative methods of providing informed consent is increasing, especially in research with marginalised (or illiterate) research participants. This article discusses the co-creation of a visual informed consent (VIC), in collaboration with an artist. The VIC was inspired by the experience of obtaining informed consent from a group of migrant women with limited English proficiency, in empirical research undertaken on agroecology and health in Coventry, UK. Reflecting further on its creation and wider utility, this article explores the inner values that might guide researchers and lead to the co-creation of care-full tools that meet the needs of research participants. Specifically, this includes, reflecting on the iterative process of developing a VIC and using an ethics of care as a primary conceptual framework. Findings reveal that participants’ understanding of ethical issues is facilitated using visual illustrations. It is argued that the creation of a VIC requires the researcher to be attentive to the embodied nature of research practice and guided by an ethics of care. A conceptual framework that integrates care and embodiment is presented, with the intention that it may further support the development of care-full research by others.

Ethical and legal challenges of medical AI on informed consent: China as an example

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Ethical and legal challenges of medical AI on informed consent: China as an example
Wang Y, Ma Z
Developing World Bioethics, 19 January 2024
Abstract
The escalating integration of Artificial Intelligence (AI) in clinical settings carries profound implications for the doctrine of informed consent, presenting challenges that necessitate immediate attention. China, in its advancement in the deployment of medical AI, is proactively engaging in the formulation of legal and ethical regulations. This paper takes China as an example to undertake a theoretical examination rooted in the principles of medical ethics and legal norms, analyzing informed consent and medical AI through relevant literature data. The study reveals that medical AI poses fundamental challenges to the accuracy, adequacy, and objectivity of information disclosed by doctors, alongside impacting patient competency and willingness to give consent. To enhance adherence to informed consent rules in the context of medical AI, this paper advocates for a shift towards a patient-centric information disclosure standard, the restructuring of medical liability rules, the augmentation of professional training, and the advancement of public understanding through educational initiatives.

Using ChatGPT to Facilitate Truly Informed Medical Consent

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Using ChatGPT to Facilitate Truly Informed Medical Consent
Fatima N. Mirza, Oliver Y. Tang, Ian D. Connolly, Hael A. Abdulrazeq, Rachel K. Lim, G. Dean Roye, Cedric Priebe, Cheryl Chandler, Tiffany J. Libby, Michael W. Groff, John H. Shin, Albert E. Telfeian, Curtis E. Doberstein, Wael F. Asaad, Ziya L. Gokaslan, James Zou, Rohaid Ali
New England Journal of Medicine AI, 10 January 2024
Abstract
Informed consent is integral to the practice of medicine. Most informed consent documents are written at a reading level that surpasses the reading comprehension level of the average American. Large language models, a type of artificial intelligence (AI) with the ability to summarize and revise content, present a novel opportunity to make the language used in consent forms more accessible to the average American and thus, improve the quality of informed consent. In this study, we present the experience of the largest health care system in the state of Rhode Island in implementing AI to improve the readability of informed consent documents, highlighting one tangible application for emerging AI in the clinical setting.

From Code to Care and Navigating Ethical Challenges in AI Healthcare

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From Code to Care and Navigating Ethical Challenges in AI Healthcare
Book Chapter
Sourav Madhur Dey, Pushan Kumar Dutta
Human-Centered Approaches in Industry 5.0: Human-Machine Interaction, Virtual Reality Training, and Customer Sentiment Analysis, 2024 [IGI Global]
Abstract
Artificial intelligence (AI) has become a transformative force in the healthcare industry, offering unprecedented opportunities for improved diagnostics, patient treatment, and outcomes. However, its integration into healthcare systems has also brought to light a host of ethical concerns that require careful scrutiny. This chapter delves into the intricate nexus of ethics and AI in healthcare, shedding light on the multifaceted implications and challenges that arise. AI technologies such as machine learning (ML) and data analytics (DS) have immense potential to revolutionize healthcare. They can enhance diagnostic accuracy, enable the treatment of a larger number of patients, and improve patient outcomes. However, their implementation is not without ethical quandaries. These primarily revolve around data privacy, bias mitigation, transparency, responsibility, and patient independence. Transparency and interpretability are other essential aspects of the ethical discourse surrounding AI in healthcare.

Study on the Reasons of Discharge with the Personal Consent of Patients Admitted to the Emergency Ward of Kowsar Hospital of Semnan, Iran

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Study on the Reasons of Discharge with the Personal Consent of Patients Admitted to the Emergency Ward of Kowsar Hospital of Semnan, Iran
Mehdi Yarahmadi, Mehri Ayati, Mohammad Taghi Ghorbanian
Journal of Guilan University of Medical Sciences, 20 January 2024
Abstract
Background
Discharge against Medical Advice (DAMA) indicates the dissatisfaction of patients with the care services of the health system. Additionally, it threatens the patient’s life and causes negative financial outcomes for hospitals.
Objective
This study aimed to identify the causes of self-discharge decisions in the emergency department at Kowsar Hospital, Semnan, Iran.
Methods
This was a descriptive-analytical study conducted between August 2021 to March 2022. The data were collected by a researcher-made questionnaire containing demographic characteristics and reasons for self-discharge, including three main concepts: personal, staff-related factors, and environmental factors with sub-concepts. Data were analyzed using SPSS.
Results
Of 140 patients with a mean age of 33.52 ± 16.17 years, 58.6% were men and 41.4% were women. Moreover, 63.6% of patients were married, 42.1% had a diploma education, and 11.4% had a history of taking neuropsychiatric drugs. Also, 42.9% of patients were covered by social security insurance. The highest rate of self-discharge was in the evening (42.1%) and night (37.9%) shifts. The most important reasons for self-discharge decision were problems related to insurance (30%), COVID-19 infection (26.4%), poor communication (17.1%), dissatisfaction with care (15.7 %), disrespectful behavior of staff (12.9%), and inappropriate emergency ward facilities (12.1%).
Conclusion
Make appropriate decisions to improve the quality of medical services and increase cooperation in health insurance, separating the departments of infectious diseases away from other departments, holding briefing sessions for physicians and medical staff, increasing awareness of patients about possible complications of self-discharge, and expanding the amenities of emergency ward can reduce the rate of self-discharge decision.

Editor’s note: The Guilan University of Medical Sciences is located in Rasht, Iran.

Compliance with research ethics in epidemiological studies targeted to conflict-affected areas in Western Ethiopia: validity of informed consent (VIC) by information comprehension and voluntariness (ICV)

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Compliance with research ethics in epidemiological studies targeted to conflict-affected areas in Western Ethiopia: validity of informed consent (VIC) by information comprehension and voluntariness (ICV)
Research
Gemechu Tiruneh, Mekdes Yilma, Bizuneh Wakuma, Eba Abdisa, Lami Bayisa, Michelle Nichols, Anja Bedeker, Nicki Tiffin
BMC Medical Ethics, 18 January 2024
Open Access
Abstract
Background
The conduct of research is critical to advancing human health. However, there are issues of ethical concern specific to the design and conduct of research in conflict settings. Conflict-affected countries often lack strong platform to support technical guidance and monitoring of research ethics, which may lead to the use of divergent ethical standards some of which are poorly elaborated and loosely enforced. Despite the growing concern about ethical issues in research, there is a dearth of information about ethical compliance in conflict areas. Valid and ethically informed decision-making is a premier pact with research participants in settling possible ethical issues before commencing the research, which is ensured by gaining informed consent from prospective participants of the research.
Aims
This research aimed to explore compliance with research ethics and consent validity in community-based epidemiological research conducted previously.
Methods
Research participants were recruited in the western part of Ethiopia in three districts subjected to conflicts. A community-based cross-sectional study design was utilized, and 338 residents were enrolled as study participants. All participants had previously been enrolled as research participants in epidemiological studies. Data was collected using a questionnaire that was pilot-tested before the commencement of the main data collection. The questionnaire focused on participants’ experiences of the informed consent process followed when they were recruited for an epidemiological study and covered themes such as essential information provided, level of comprehension, and voluntarism of consent.
Results
Over half of the study participants, 176 (52%), were not provided with essential information before consenting. And 135 (40%) of them did not comprehend the information provided to them. One hundred and ninety (56%) participants freely and voluntarily agreed to partake in one of these epidemiological studies, with over a quarter (97; 28.7%) of them reporting they were subjected to undue influence. Written consent was obtained from only 32 (9.4%) of the participants.